The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis

NCT04146480 | Unknown

• 1 other identifier: TASMC-17-ES-0807-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac amyloidosis is a common cause of refractory cardiomyopathy and heart failure in an adult population. There are several types of cardiac amyloidosis, but two are the most common (1): A. AL - Light chain sunset. B. ATTR - Sunset of transthyretin protein. This amyloidosis has two subtypes:

1. 1.Hereditary / familial - due to genetic mutation
2. 2.Senile / Wild-type (WT) - Acquired with age

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value

  1 year

Study Arms (1)

Cardiac amyloidosis patients

EXPERIMENTAL

Diagnostic Test: F18-NaF PET/CT

Interventions

F18-NaF PET/CT DIAGNOSTIC_TEST

The scan will be performed on the Discovery 690 Nuclear Medicine Camera. On the day of the scan, the patient will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Prior to the scan, the subject will undergo a brief interview by a physician or nurse and a 22 G Prefill will be installed on him, through which a 5 millikiric (mCi) of 18 F-NaF will be injected. 4\. An hour after the injection, the PET / CT scan, which will last about 10 minutes, during, the patient is required to lie down and breathe normally. 5\. Upon completion of the scan, will be released without any restrictions.

Cardiac amyloidosis patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
• B. Patients who performed 99mTc-PYP mapping and signed an informed consent form to perform another imaging test, namely, 18F-NaF PET / CT.

You may not qualify if:

• None

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky medial center, Tel Aviv, Israel

Tel Aviv, Central District, 6436110, Israel

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

Ira korovin

CONTACT

036974373; irako@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: July 1, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 24, 2020
• Last Updated: October 31, 2019

Record last verified: 2019-05

Locations

IL (1)